** Shares in Camurus CAMX.ST fall 7% after the U.S. Food and Drug Administration rejected its application for Oclaiz acromegaly, a hormonal disorder, potentially delaying the drug's launch

** The FDA requested a reinspection of the third-party manufacturing facility and a small labelling change to the product packaging

** Assuming the reinspection takes place in H2 2026, approval and launch would shift to H1 2027, Jefferies says

** "While a negative near-term regulatory development, the CRL does not impact our view on Oclaiz's commercial opportunity, representing ~9% of our current valuation," Van Lanschot Kempen says

** The rejection does not relate to the clinical efficacy or safety of the drug and does not change Camurus' 2026 outlook

** Acromegaly is a hormonal disorder that causes abnormal growth of bones and tissues, body parts and inner organs